Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

ZVU Functional GI Software Recalled by Diversatek Healthcare Due to GI Software labelled as revision 3.3.0 is incorrectly...

Date: July 25, 2023
Company: Diversatek Healthcare
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Diversatek Healthcare directly.

Affected Products

ZVU Functional GI Software, REF: ZVU-3

Quantity: 20

Why Was This Recalled?

GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Diversatek Healthcare

Diversatek Healthcare has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report